Doxorubicin Hydrochloride Injection
»Doxorubicin Hydrochloride Injection is a sterile solution of Doxorubicin Hydrochloride in Sterile Water for Injection made isoosmotic with Sodium Chloride,Dextrose,or other suitable added substances.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C27H29NO11·HCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.Store in a refrigerator.Injection may be packaged in multiple-dose containers not exceeding 100mLin volume.
Identification— When chromatographed as directed in the Assay,the Assay preparationexhibits a major peak for doxorubicin,the retention time of which corresponds to that exhibited by the Standard preparation.
Bacterial endotoxins á85ñ— Use a test solution prepared by diluting Doxorubicin Hydrochloride Injection with Sterile Water for Injection to obtain a concentration of 1.1mg of doxorubicin hydrochloride per mL:the specimen under test contains not more than 2.2USP Endotoxin Units per mg of doxorubicin hydrochloride.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,the entire contents of all the containers being collected aseptically.
pHá791ñ: between 2.5and 4.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Resolution solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Doxorubicin Hydrochloride.
Assay preparation— Dilute an accurately measured volume of Injection,equivalent to not less than 2mg of doxorubicin hydrochloride,quantitatively with Mobile phaseto obtain a solution containing about 0.1mg of doxorubicin hydrochloride per mL,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Doxorubicin Hydrochloride.Calculate the quantity,in mg,of C27H29NO11·HCl in each mLof the Injection taken by the formula:
(CP/1000)(L/D)(rU/rS),
in which Lis the labeled quantity,in mg per mL,of doxorubicin hydrochloride in the Doxorubicin Hydrochloride Injection taken,Dis the concentration,in mg per mL,of doxorubicin hydrochloride in the Assay preparation,on the basis of the labeled quantity in the volume of Injection taken and the extent of dilution,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 696
Phone Number:1-301-816-8335